Exercise Training in Women With Metastatic Breast Cancer

NCT07521826 | Not Yet Recruiting

• 1 other identifier: 6.766.609
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.

Conditions

Cancer; Metastases

Keywords

Low muscle strength; muscle loss; loss of physical function; cardiorespiratory fitness; multimodal exercise

Outcome Measures

Primary Outcomes (3)

• Cardiorespiratory endurance and functional capacity

  6MWT was performed as a parameter of cardiorespiratory endurance and functional capacity. Participants were instructed to walk back and forth along a flat, straight 25m corridor for six minutes, covering as much distance as possible at a self-selected pace. The total distance walked (in meters) was recorded as the primary outcome.

  Baseline and week 24 (post exercise intervention)

• Lower-limb muscle strength

  Lower-limb muscle strength was assessed using the five-repetition sit-to-stand test (5xSTS), according to the European Working Group on Sarcopenia in Older People (EWGSOP2)¹. Participants were instructed to stand up and sit down five times as quickly as possible, with their arms crossed over the chest. The total time to complete the test was recorded in seconds (s) and used as an indicator of muscle strength. All assessments were performed by a trained evaluator

  Baseline and week 24 (post exercise intervention)

• Handgrip strength

  Muscle strength was assessed using a handgrip dynamometer (SH5001, Saehan Grip, South Korea). Participants performed three maximal voluntary contractions with each hand in an alternating sequence, with a one-minute rest interval between trials. The highest value (kg) achieved was used for analysis. All measurements wer

  Baseline and week 24 (post exercise intervention)

Secondary Outcomes (3)

• Body composition

  Baseline and week 24 (post exercise intervention)

• Health-related quality of life

  Baseline and week 24 (post exercise intervention)

• Fatigue

  Baseline and week 24 (post exercise intervention)

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group will be instructed to complete 48 supervised, multicomponent physical training sessions over a 24-week period, with a frequency of two sessions per week on non-consecutive days.

Other: Exercise

Control group

NO INTERVENTION

Participants in the waitlist control group received standard medical care, without any exercise program or specific exercise recommendations. To maintain contact with the investigators and minimize study dropout, the waitlist control group received general health information through monthly online meetings.

Interventions

Exercise OTHER

The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting the major muscle groups of the upper and lower body to improve strength and muscle mass. Six to eight exercises were performed using body weight, resistance bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the Borg 0-10 rating of perceived exertion scale, when health status allowed. The aerobic component consisted of walking, progressing to beginner-level running using short running intervals (50-100 m) interspersed with walking until longer continuous distances were achieved. Heart rate was monitored throughout the aerobic session.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility was based on biological sex characteristics relevant to breast cancer, as this condition is directly related to the presence of breast tissue and exposure to specific hormonal factors that may influence both disease progression and responses to the proposed interventions. Therefore, inclusion criteria were defined based on essential biological characteristics to ensure sample homogeneity and the validity of the study outcomes. Gender identity was respected and recorded; however, eligibility criteria were determined by the biological characteristics required for the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥ 18 years;
• Confirmed diagnosis of stage IV (metastatic) breast cancer;
• Currently undergoing medical treatment;
• Willingness and functional independence to participate in the exercise program;
• Medical clearance to engage in structured physical exercise.

You may not qualify if:

• Presence of unstable bone metastases.
• Untreated or symptomatic brain metastases;
• Evidence of severe cardiovascular disease identified by electrocardiogram (ECG);
• Severe active infection;
• Uncontrolled severe respiratory insufficiency or dependence on supplemental oxygen at rest or during exercise;
• Uncontrolled severe pain;
• Any other medical condition contraindicating participation in physical exercise;
• Conditions that impair adherence to study procedures or the ability to provide informed consent;
• Pregnancy.

Sponsors & Collaborators

• State University of Londrina: lead

Study Sites (1)

Universidade Estadual de Londrina, Londrina

Londrina, Paraná, 86047-597, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Muscular Atrophy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rafael Deminice, PhD

CONTACT

+5543991916013; rdeminice@uel.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators were not blinded to group assignment, given the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BR (1)